Infertility Clinical Trial
— CLC IIOfficial title:
Randomized Controlled Trial of Combined Letrozole and Clomid (CLC II) Versus Letrozole Alone for Women With Anovulation
Verified date | December 2023 |
Source | University of Iowa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates the addition of clomiphene citrate (CC) to letrozole for the treatment of infertility in women with polycystic ovary syndrome across a course of two treatment cycles with stair step dosing of letrozole similar to standard of care. Half of the participants will receive letrozole and CC in combination, while the other half will receive letrozole alone.
Status | Active, not recruiting |
Enrollment | 189 |
Est. completion date | December 2024 |
Est. primary completion date | March 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: 1. Willing to comply with all study procedures and be available for the duration of the study 2. Diagnosis of infertility: Inability of couple to achieve successful pregnancy after 12 months of regular time unprotected intercourse in women less than 35 years of age; and after 6 months of regular intercourse without use of contraception in women 35 years and older. Women that have anovulation or oligomenorrhea are also considered to meet diagnosis of infertility, without meeting the time constraints described above. 3. Diagnosis of polycystic ovary syndrome based on Revised Rotterdam criteria. 4. Ability to have regular intercourse during the ovulation induction phase of the study. 5. Partner with a normal sperm concentration of 15 million/mL and with normal motility of >40% according to World Health Organization cutoff points or greater than 10 million total motile sperm count OR has fathered a pregnancy in the past. Exclusion Criteria: 1. Current pregnancy 2. Current use of hormonal contraception; use of any type of combined contraceptive or oral progestins within the past month; or use of hormonal implants or depo progestins within the past 3 months 3. Other known cause of infertility: endometriosis, tubal factor, uterine abnormalities 4. Uncorrected thyroid disease 5. Untreated hyperprolactinemia 6. Medical conditions in which avoiding pregnancy is recommended until under improved control: poorly controlled Type 1 or Type 2 diabetes, poorly controlled hypertension 7. Contraindications to clomiphene citrate: hypersensitivity to clomiphene citrate or any of its components, history of liver disease or known liver disease, unknown cause of abnormal uterine bleeding, or intracranial lesion 8. Contraindications to letrozole: hypersensitivity to letrozole or any of its components 9. Use of medications known to affect reproductive function or metabolism or that are an absolute contraindication during pregnancy within the past month 10. If patients are suspected based on clinical findings for other etiologies that mimic PCOS, work up must be completed to exclude other etiologies prior to enrollment (i.e. Cushing's syndrome, androgen-secreting tumor) |
Country | Name | City | State |
---|---|---|---|
United States | University of Iowa Hospitals & Clinics - Davenport Clinic | Davenport | Iowa |
United States | University of Iowa Hospitals & Clinics | Iowa City | Iowa |
United States | University of Wisconsin | Madison | Wisconsin |
United States | University of Iowa Hospitals & Clinics- West Des Moines Clinic | West Des Moines | Iowa |
Lead Sponsor | Collaborator |
---|---|
Rachel Mejia | American Society for Reproductive Medicine, Society for Reproductive Investigation, University of Wisconsin, Madison |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ovulation | Mid-luteal serum progesterone level >=3 ng/ml | Tested 6 to 8 days following patient reporting a positive ovulation test (LH surge). If no surge is detected, progesterone lab will be drawn on Cycle day 21-24. | |
Secondary | Number of corpora lutea | Number of corpora lutea on ultrasound | Cycle day 21-24 of 1st treatment cycle | |
Secondary | Number of corpora lutea | Number of corpora lutea on ultrasound | Cycle day 21-24 of 2nd treatment cycle | |
Secondary | Number of corpora lutea | Number of corpora lutea on ultrasound | Cycle day 21-24 of 3rd treatment cycle | |
Secondary | Endometrial thickness | Endometrial thickness assessed by ultrasound | Cycle day 21-24 of 1st treatment cycle | |
Secondary | Endometrial thickness | Endometrial thickness assessed by ultrasound | Cycle day 21-24 of 2nd treatment cycle | |
Secondary | Endometrial thickness | Endometrial thickness assessed by ultrasound | Cycle day 21-24 of 3rd treatment cycle | |
Secondary | Conception | positive serum or urinary test of hCG | 5 weeks after treatment in treatment cycles 1, 2, and 3 (treatment cycle is 24-35 days depending on ovulation) | |
Secondary | Clinical pregnancy | intrauterine pregnancy with fetal heart motion determined by ultrasound | 6 to 7 weeks after treatment in treatment cycles 1, 2, and 3 (treatment cycle is 24-35 days depending on ovulation) | |
Secondary | Multiple gestation | intrauterine pregnancy with more than one fetal heart motion determined by ultrasound | 6 to 7 weeks after treatment in treatment cycles 1, 2, and 3 (treatment cycle is 24-35 days depending on ovulation) | |
Secondary | Live birth | delivery of a live born infant determined by medical record abstraction | 9-10 months following final treatment cycle (treatment cycle is 24-35 days depending on ovulation) | |
Secondary | Multiple birth | delivery of more than one infant determined by medical record abstraction | 9-10 months following final treatment cycle (treatment cycle is 24-35 days depending on ovulation) | |
Secondary | Pregnancy Loss | biochemical pregnancy, miscarriage, or ectopic pregnancy determined by ultrasound or medical record abstraction | Through study completion, an average of 1 year |
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